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44898
Beschrijving
Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs
Link
https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs
Trefwoorden
Versies (2)
- 24-04-18 24-04-18 - Halim Ugurlu
- 01-04-22 01-04-22 - Martin Dugas
Houder van rechten
GSK
Geüploaded op
1 april 2022
DOI
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Licentie
Creative Commons BY-NC 4.0
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GSK Study ID 104864-201 Laboratory Tests
Laboratory Tests
- StudyEvent: GSK Study ID 104864-201 Laboratory Tests
Similar models
Laboratory Tests
- StudyEvent: GSK Study ID 104864-201 Laboratory Tests
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Laboratory Tests-Hematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
Visit
Item
Visit
text
C0545082 (UMLS CUI [1])
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
RBC
Item
RBC
float
C0014772 (UMLS CUI [1])
WBC
Item
WBC
text
C0023508 (UMLS CUI [1])
Neutrophils - segmented
Item
Neutrophils - segmented
float
C0229640 (UMLS CUI [1])
Bands
Item
Bands
float
C1882076 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
float
C0200635 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0026473 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
float
C0857996 (UMLS CUI [1])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])
Blast Cells
Item
Blast Cells
float
C0368761 (UMLS CUI [1])
Prothrombin Time (PT)
Item
Prothrombin Time (PT)
float
C0033707 (UMLS CUI [1])
Partial Thromboplastin Time
Item
Partial Thromboplastin Time
float
C3525810 (UMLS CUI [1])
Fibrinogen
Item
Fibrinogen
float
C0016006 (UMLS CUI [1])
Item Group
Laboratory Tests-Blood Chemistry
C1254595 (UMLS CUI-1)
C0005774 (UMLS CUI-2)
C0005774 (UMLS CUI-2)
Visit
Item
Visit
text
C0545082 (UMLS CUI [1])
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
Bicarbonate
Item
Bicarbonate
float
C0202059 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Phosphorus
Item
Phosphorus
float
C0031705 (UMLS CUI [1])
Magnesium
Item
Magnesium
float
C0373675 (UMLS CUI [1])
BUN
Item
BUN
float
C0005845 (UMLS CUI [1])
Urea
Item
Urea
float
C0523961 (UMLS CUI [1])
Uric Asid
Item
Uric Asid
float
C0202239 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
SGOT/AST
Item
SGOT/AST
float
C0201899 (UMLS CUI [1])
SGPT/ALT
Item
SGPT/ALT
float
C0201836 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
Direct Bilirubin
Item
Direct Bilirubin
float
C0201916 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Creatinine Clearance
Item
Creatinine Clearance
float
C0373595 (UMLS CUI [1])
Serum Beta HCG
Item
Serum Beta HCG
float
C2348195 (UMLS CUI [1])
Item
Are there clinically significant abnormal laboratory values?
text
C0438215 (UMLS CUI [1])
Code List
Are there clinically significant abnormal laboratory values?
CL Item
No (1)
CL Item
Yes (If 'Yes', record findings and/or diagnosis on page for Screening or in the Adverse Experience section) (2)
Item Group
Laboratory Tests-Urinalysis
C0042014 (UMLS CUI-1)
C0587081 (UMLS CUI-2)
C0587081 (UMLS CUI-2)
Visit
Item
Visit
text
C0545082 (UMLS CUI [1])
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Protein
Item
Protein
float
C0262923 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0004076 (UMLS CUI [1])
Blood
Item
Blood
float
C0202514 (UMLS CUI [1])
Microscopy of Urin
Item
Was microscopy performed?
boolean
C0430397 (UMLS CUI [1])
RBC/HPF
Item
RBC/HPF
float
C4039763 (UMLS CUI [1])
WBC/HPF
Item
WBC/HPF
float
C4039553 (UMLS CUI [1])
Casts/LPF
Item
Casts/LPF
float
C0439356 (UMLS CUI [1])
CL Item
Negative (0)
CL Item
1-2 (Few) (1)
CL Item
>2(Many) (3)
Are there clinically significant abnormal laboratory values?
Item
Are there clinically significant abnormal laboratory values?
boolean
C0438215 (UMLS CUI [1])
Item Group
Laboratory Tests-Bone Marrow Examination
C0005957 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0022885 (UMLS CUI-2)
Visit
Item
Visit
text
C0545082 (UMLS CUI [1])
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Pronormoblasts
Item
Pronormoblasts
float
C2350150 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Basophilic Normoblasts
Item
Basophilic Normoblasts
float
C2238288 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Polychromatophilic Normoblasts
Item
Polychromatophilic Normoblasts
float
C2238289 (UMLS CUI [1])
Orthochromatic Normoblasts
Item
Orthochromatic Normoblasts
float
C2238290 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C4028217 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Eosinophils
Item
Eosinophils
float
C1171399 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Basophils
Item
Basophils
float
C0549791 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Bands
Item
Bands
float
C1882076 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Metamyelocytes
Item
Metamyelocytes
float
C0229635 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Myelocytes
Item
Myelocytes
float
C0369715 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Promyelocytes
Item
Promyelocytes
float
C0033416 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Myeloblasts
Item
Myeloblasts
float
C0229633 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Lymphocytes
Item
Lymphocytes
float
C0200635 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Plasma Cells
Item
Plasma Cells
float
C0032112 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Monocytes
Item
Monocytes
float
C0026473 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Reticulum Cells
Item
Reticulum Cells
float
C2238294 (UMLS CUI [1])
Megakaryocytes
Item
Megakaryocytes
float
C0025166 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Myeloid Erythroid Ratio
Item
Myeloid Erythroid Ratio
float
C2238284 (UMLS CUI [1])
CL Item
Aplastic (1)
CL Item
Hypocellular (2)
CL Item
Normacellular (3)
CL Item
Hypercellular (4)
CL Item
Packed (5)
CL Item
Normal (1)
CL Item
Abnormal (2)
Splenomegaly
Item
Does the patient have splenomegaly?
boolean
C0038002 (UMLS CUI [1])
Extramedullary disease or soft tissue involvement
Item
Does the patient have extramedullary disease or soft tissue involvement?
boolean
C1515974 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C1517060 (UMLS CUI [1,4])
C0225317 (UMLS CUI [2])
C0012634 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C1517060 (UMLS CUI [1,4])
C0225317 (UMLS CUI [2])
If yes to Extramedullary disease or soft tissue involvement
Item
If yes to Extramedullary disease or soft tissue involvement, please record the site(s)
text
C1515974 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C1517060 (UMLS CUI [1,4])
C0225317 (UMLS CUI [2])
C0012634 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C1517060 (UMLS CUI [1,4])
C0225317 (UMLS CUI [2])
Visit
Item
Visit
text
C0545082 (UMLS CUI [1])
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Item
Chromosome Abnormalities Present
text
C4015468 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
-5/del (5q) (1)
CL Item
-7/del (7q) (2)
CL Item
+8 (3)
CL Item
+9 del(9q) (4)
CL Item
-11q (5)
CL Item
-12p (6)
CL Item
del(13q) (7)
CL Item
-18 (8)
CL Item
+19 (9)
CL Item
+21 (10)
CL Item
3q21-26 (11)
CL Item
t(1;7) (12)
CL Item
Other, Specify.... (13)
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